Various medical procedures, including in particular hemodialysis, involve the surgical installation of one or more grafts to facilitate access to the blood flow of the patient. Currently hemodialysis patients undergo repetitive, often painful large needle punctures of their skin and underlying tissue numerous times per week to gain entry into such grafts. The disadvantages of this approach are numerous and well documented. Hematomas can result from uncontrolled bleeding. The graft is damaged by the multiple puncture technique leading ultimately to poor and inadequate functioning or thrombosis resulting in the need for additional operations, replacement of the graft and resultant tissue trauma. Temporary access through internal jugular veins or other venous access sites further adds to patient morbidity.
Significant technical expertise and nursing care is currently required to puncture the grafts. Following the procedure and needle removal, skilled nursing staff are required to hold pressure on the graft puncture site for variable periods of time which not infrequently last up to an hour, or more.
The present invention comprises a surface access hemostatic valve for medical use which overcomes the foregoing and other problems long since associated with the prior art. In accordance with the broader aspects of the invention, a surface access hemostatic valve includes a tube connected in fluid communication with a graft and extending from the graft to a hemostatic valve situated at the outer surface of the skin of the patient. Access to the blood flow of the patient is achieved by inserting an instrument through the hemostatic valve through the tube and into the graft.
The advantages obtained by means of the invention include the following:
1. Decreased patient suffering.
2. Increased patient comfort and satisfaction.
3. No needle damage to the graft.
4. Longer lifetime of the graft.
5. Decreased number of surgical procedures in the lifetime of the patient.
6. Decreased cost of medical care.
7. Improved graft functioning with greater flow rates and decreased procedure time.
8. Decreased nursing staff time without difficult, highly skilled punctures having to be performed.
9. Decreased post procedure time with no requirement for applying pressure at the puncture site to control bleeding.
10. Further potential for improving graft design by strengthening the material used as graft punctures are no longer required.
11. Decreased number of graft-related complications for patients undergoing long-term care with fewer hematomas (therefore less associated vein, nerve, and arterial compression with less deep venous thrombosis and decreased potential for decreased use of the extremity), less potential for arterial embolic disease, less exposure to the risks of anesthesia with decreased need for surgical intervention or radiologic declot intervention.
12. Decreased damage to the entire venous system of the patient with decreased need for temporary access to other large caliber veins because of graft malfunction.
13. Safe and efficient access for monitoring the graft to prevent significant stenoses and occlusions.
14. Facilitates endoluminal placement of a short segment graft extension without damage to the existing graft.
15. Allows less intensively trained personnel to take care of patients.
16. Safe and easy access for administering thrombolytic agents to dissolve clots that develop in grafts.